Tougher rules eyed for drugs shipped to California

State regulators are looking at ways to beef up laws regarding shipments of products from out-of-state compounding pharmacies into California, in the wake of the national meningitis outbreak caused by a contaminated drug made by a Massachusetts company.

Virginia Herold, executive officer of the California Board of Pharmacy, which licenses pharmacies in the state and those that ship products into California, said she would be taking proposed legislation to the board at its next meeting on Oct. 25-26.

Herold said the proposals are still being worked on but would target licensing requirements for out-of-state compounding pharmacies that ship to California.

The regulations could require, among other things, that accrediting agencies use California inspection standards for any out-of-state manufacturers who ship to California, she said.

“If we’re going to accept their accreditation it should be to our standards,” she said.

As of Wednesday, 137 people in 10 states — none in California — have developed meningitis linked to an injectible pain drug made by the New England Compounding Center and shipped around the country. Twelve people have died, according to the U.S. Centers for Disease Control and Prevention.

According to the CDC, four California clinics received shipments of the drug, which was recalled on Sept. 26.

Between 500 and 600 patients may have received the injection at those clinics in Visalia, Encino, Ukiah and Palmdale, said Ralph Montano, a spokesman for the California Department of Public Health. “There have been no reports of illness,” he said.

The drug, a steroid called methylprednisolone acetate that is injected into the spine, was contaminated by a fungus. As many as 13,000 people may have gotten the drug between May 21 and Sept. 24, according to the CDC.

The situation has highlighted how compounding pharmacies such as the Massachusetts company are regulated. Compounding pharmacies typically make customized medications for specific patients in doses or forms that aren’t commercially available, but some have moved into large-scale production with products shipped nationwide.

Compounding pharmacies are licensed by states, while drug manufacturers are regulated by the U.S. Food and Drug Administration.

“What’s difficult to discern is when compounding becomes manufacturing,” Herold said. “The FDA has tried several times to define manufacturing and has been challenged on that.”

With the meningitis cases mounting, some members of Congress have called this week for tougher FDA oversight.

The California Board of Pharmacy licenses 6,286 community pharmacies and any of them can do compounding such as adding flavoring, making liquid medications, or changing dosages, Herold said. Specialty licenses have been issued to 280 pharmacies in the state to do sterile injectible compounding, she said.

California pharmacies are required to meet regulations that include an annual inspection, she said.

New England Compounding Center had one of those licenses, but the board issued a cease and desist order on Oct. 4 that prevents it from shipping any products to California. The order remains in effect indefinitely, until reversed by the board.

Herold said that, although the Massachusetts company has ceased manufacturing for now, she wanted the order in place in case it resumes production.

“California and the U.S. in general has the safest drug supply in the world,” she said, “But that doesn’t necessarily meant this isn’t a problem.”

Patients receiving injected drugs should ask their doctor where it came from and physicians should make sure the drug is from a licensed facility, she said.

Anyone who has symptoms identified by the CDC for meningitis — fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site — should contact their doctor.